Targeted approach for detecting and treating metastatic cancer
A Novel Molecularly Targeted Theranostic Approach Via the αvβ6 Integrin for the Detection and Treatment of Metastatic Carcinomas
This study is testing a new way to find and treat metastatic cancer using special imaging and a targeted treatment to see if it helps patients who haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06389123 on ClinicalTrials.gov |
What this trial studies
This Phase I study evaluates the safety and efficacy of the theranostic pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in patients with metastatic cancer. The study utilizes [68Ga]Ga DOTA-5G PET/CT imaging to identify patients who are most likely to respond to the treatment. Up to 40 patients will be enrolled over a 36-month period, focusing on those with documented disease progression after prior treatments. The study aims to determine if this approach can effectively detect lesions and provide a therapeutic response with a single dose of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with pathologically confirmed metastatic cancers who have shown disease progression after at least one prior treatment.
Not a fit: Patients with non-metastatic cancer or those who have not undergone prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve detection and treatment outcomes for patients with metastatic cancer.
How similar studies have performed: Other studies have shown promise with theranostic approaches in cancer treatment, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 or more years 3. Pathologically confirmed GU, GI, GYN breast, cervical, uterine, or head and neck cancers with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis) 4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging. 5. Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available. 6. Eastern Cooperative Oncology Group Performance Status ≤ 2 7. Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline. 8. Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN 10. Anticipated life expectancy ≥ 3 months 11. Able to remain motionless for up to 30-60 minutes per scan \[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria: 1. Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan 2. The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Exclusion Criteria: \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria: 1. Participants with Class 3 or 4 NYHA Congestive Heart Failure 2. Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding) 3. Pregnant or lactating women 4. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks 5. Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix) 6. Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy 7. Psychiatric illness/social situations that would interfere with compliance with study requirements 8. Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.) 9. Pathologically confirmed NSCLC with metastatic disease 10. INR \>2.0: PTT\>15 seconds above ULN 11. Participant on therapeutic warfarin anticoagulation 12. External beam radiation therapy (EBRT) or radiopharmaceutical treatment within 21 days prior to study day 1
Where this trial is running
Sacramento, California
- The University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Julie L Sutcliffe — University of California, Davis
- Study coordinator: Julie L Sutcliffe, Phd
- Email: jlsutcliffe@ucdavis.edu
- Phone: 9167345536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.